European Committee for Standardization releases new methods for nitrosamines and nitrosamines in rubber pacifiers and pacifiers

by:Ennas      2022-01-04
The European Committee for Standardization (CEN) released EN 12868:2017 for the release of nitrosamines and nitrosamines from medium elastomer or rubber pacifiers and pacifiers...   [Chinese and foreign toy network March 24, 2017] European Committee for Standardization (CEN) issued EN 12868:2017 for the release of nitrosamines and nitrosamines from medium elastomer or rubber pacifiers and pacifiers. The conflicting national standards will be withdrawn before July 2017.   In April 1993, the European Union (EU) issued the 93/11/EEC Directive [1], restricting the release of nitrosamines and nitroso substances from elastomer or rubber pacifiers and pacifiers. The directive also stipulates the basic principles and analytical methods for the detection of such substances.   In August 1999, CEN issued EN 12868:1999 as a standard method that meets the requirements of the 93/11/EEC directive. This standard provides detailed extraction and analysis procedures for nitrosamines and nitroso substances in rubber pacifiers and pacifiers.   In October 2016, CEN approved the new standard EN 12868:2017 related to nitrosamines and nitroso substances in elastomer or rubber pacifiers and pacifiers. This standard is a commercial standard and can be obtained from national standards organizations such as the British Standards Institute (BSI[2]). EN 12868:2017 has made changes to the 1999 edition, which are mainly reflected in:   - redefine 'n-nitrosamines' and 'ready-to-use products';   - change the definitions of 'elastomer' and 'rubber';   - required to proceed Two migration tests and two determinations;   - change the procedure, including the temperature of nitrosation, and specify the minimum sample size of elastomer samples and rubber in the test;   - change N-nitroso diisobutylamine (NDiBA, CAS No. 997-95-5) is classified as an identifiable nitrosamine in a pacifier, which is related to testing and calibration standards;   -Provides n-nitrosamine calibration liquid gas chromatography (GC) and thermal analysis The retention time obtained by the TEA detector is used for auxiliary analysis (Appendix B);   -Liquid chromatography-mass spectrometry (LC-MSn) is used as an alternative analysis method for nitrosamines and nitroso substances. See Annex D of this standard for technical settings.   It should be noted that the analysis tolerances of the 1999 edition and the 2017 edition of EN 12868 are the same. The total tolerance for nitrosamines is 0.01 mg/kg, and the total tolerance for nitroso substances is 0.1 mg/kg.   EN 12868:2017 or its previous version and toy safety standard EN 71-12 both detect nitrosamines and nitroso substances. It should be noted that the extraction and analysis procedures of the two methods are different.   Table 1 summarizes the main content of the 93/11/EEC directive, as well as EN 12868 (two versions) for detecting nitrosamines and nitroso substances in elastomers and rubber pacifiers and pacifiers.  Through a network of laboratories around the world, SGS can provide various services, including the analysis, testing and consulting of nitrosamine substances and nitrosamine substances in toys, rubber pacifiers and pacifiers in the EU and international markets. >Information provided: SGS Shenzhen Branch (SGS)    Contact:    Toys and Infant Products Service Shenzhen Tel: +86 (0)755 2532 8315   Qingdao Tel: +86 (0)532 6899 9188   Please pay attention Official WeChat: SGS toy and infant product testing service for more information.
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